The draft bill would amend the FFDCA (Federal Food, Drug, and Cosmetic Act) to add new requirements for drug manufacturers, re-packagers, wholesale distributors and dispensers to ensure that each stage of the downstream supply chain can be verified and can root out illegitimate products. The plan for such a system has been in the works for a few years, but never with bipartisan backing from Sens. Lamar Alexander (R – Tenn.), Michael Bennet (D – Colo.), Richard Burr (R - NC) and Tom Harkin (D - Iowa).
“Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves,” Bennet said. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death. This draft bill would put steps in place to prevent and reduce those problems and help ensure our drug supply is safe.”
The new requirements aim to further strengthen pharmaceutical supply chain security by requiring that no later than one year after the bill is enacted, drug manufacturers, repackagers, wholesale distributors, third-party logistics providers and dispensers “must be properly registered or licensed,” according to the Senate HELP (Health, Education, Labor and Pensions) committee’s breakdown of the draft.
A publically-accessible database of wholesalers will be also added to the US FDA’s website, according to the draft.
But the timeline for serializing drugs and ensuring that only serialized products are accepted and transferred will be phased in for the various players:
- Manufacturers will have four years after the date of enactment of the Act;
- Repackagers will have five years;
- Wholesale distributors and third-party logistics providers will have six years; and
- Dispensers will have seven years.
Failure to comply with lot-level tracing requirements would subject a manufacturer or other distribution entity to penalties, including misbranding violations under the law.
Third-party logistics providers beginning in the first year after the Act is signed will also have to report to the HHS (Health and Human Services) Secretary on an annual basis on the state by which the facility is licensed and the name and address of the facility. HHS will have to run a licensing program if a state chooses not to establish such a program for its third-party logistics providers.
Ten years after the potential law comes into effect, an interoperable, "electronic unit-level" tracing system would be established. The HHS Secretary also would be required at this future date to contract with a private, independent consulting firm to assess the feasibility of unit-level product tracing requirements on dispensers with 25 or fewer full-time employees.
Comments on the draft bill are required by Friday and should be submitted to drugdistributionsecurity@help.senate.gov.
Previous Missteps
This latest bipartisan draft follows a number of unsuccessful attempts by both chambers of Congress to include track and trace provisions in federal legislation.
Originally track and trace was supposed to be a part of the re-authorization of the user fee legislation, known as FDASIA (Food and Drug Administration Safety and Innovation Act), but disagreements over whether products should be tracked at the unit level or the lot level proved too difficult to iron out and that portion of the legislation was dropped.
Efforts at the state level, particularly in California, have seen progress, though this latest bill would ensure that the federal legislation pre-empts any state efforts. Previously, companies called for such pre-emption and questioned whether certain drug products, such as injectable allergenic extracts, should be excluded from the requirements.
On Thursday, the House Energy and Commerce Subcommittee on Health also will discuss the security of the pharma supply chain in a hearing. A discussion draft on the related legislation will be circulated prior to the hearing, as well as the majority memorandum, a witness list and witness testimony, all of which will be available here as they are posted.